Contraindications
BOTOX® treatment is contraindicated in the presence of infection
at the proposed injection site(s) and in individuals with known hypersensitivity
to any ingredient in the formulation.
Warnings
The recommended dosage and frequency of BOTOX® administration should
not be exceeded. Risks resulting from administration at higher dosages are not known.
Serious and/or immediate hypersensitivity reactions have been rarely reported. These
reactions include anaphylaxis, urticaria, soft tissue edema, and dyspnea. If such
a reaction occurs, further BOTOX® injection should be discontinued
and appropriate medical therapy immediately instituted. BOTOX® should
only be diluted with 0.9% nonpreserved sodium chloride.
Individuals with peripheral motor neuropathic diseases (eg, amyotrophic lateral sclerosis
or motor neuropathy) or neuromuscular junctional disorders (eg, myasthenia gravis
or Lambert-Eaton syndrome) should only receive BOTOX® treatment
with caution. Patients with neuromuscular disorders may be at increased risk of
clinically significant systemic effects including severe dysphagia and respiratory
compromise from typical doses of BOTOX®.
Precautions
Individuals should be evaluated for potential causes of secondary hyperhidrosis (eg,
hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis
and/or treatment of the underlying disease.
The effect of administering different botulinum neurotoxin serotypes at the same
time or within several months of each other is unknown. Excessive neuromuscular
weakness may be exacerbated by administration of another botulinum toxin prior to
the resolution of the effects of a previously administered botulinum toxin.
There are no adequate and well-controlled studies of BOTOX® treatment
in pregnant women. BOTOX® should be administered during pregnancy
only if the potential benefit justifies the potential risk to the fetus. If this
drug is used during pregnancy, or if the patient becomes pregnant while taking this
drug, the patient should be apprised of the potential risks, including abortion
or fetal malformations, which have been observed in rabbits.
Adverse reactions
There have been rare reports of adverse events involving the cardiovascular system,
including arrhythmia and myocardial infarction, some with fatal outcomes. Some of
these patients had risk factors including cardiovascular disease. The exact relationship
of these events to the botulinum toxin injection has not been established.
The most frequently reported adverse events (3% to 10% of patients) following BOTOX®
injection for excessive primary axillary hyperhidrosis included
injection-site pain and hemorrhage, non-axillary sweating, infection, pharyngitis,
flu syndrome, headache, fever, neck or back pain, pruritus, and anxiety.
For more information, please see the full
prescribing information.